Medical device manufacturer Optiscan Imaging (ASX: OIL) has expanded its U.S push, opening an office in the biotech hub of Minnesota with two well-credentialed hires that have experience in dealing with both clinical trials and governmental medical departments.
Optiscan has appointed Ken Lock as Head of Clinical Affairs, with Nicole Williams being appointed Head of Regulatory Affairs. Both will man the US office.
The company says Lock is experienced in running global clinical trials that have supported the commercialisation of various classes of medical devices in the U.S. He also has experience with the Food and Drug Administration (FDA), including clinical strategy development, experience in selecting clinical trial sites, trial submissions and outcome reporting.
He has worked with physicians post-trial, to publish the results from the clinical trials completed and he has worked as a senior director of clinical affairs for both big and small companies, including St. Jude Medical and Boston Scientific. Mr Lock was also formally the vice-president of clinical affairs for both Stereotaxis and Occlutech.
Optiscan says Nicole Williams has experience in medical devices and medical device reprocessors, having worked recently with the large sterilisation-technology company Sterilucent, where she worked as Director of Clinical & Regulatory Affairs.
For more than 20 years, Williams has prepared multiple submissions leading to regulatory approvals and maintained global registrations. Notably she also has experience with surgical endoscopes and sterilisation and she has worked across multiple medical device types, including development, regulatory, quality, sales and software roles.
Both Ken and Nicole bring a wealth of relevant and critical experience and expertise to support the Company’s expansion in the US as we roll out our portfolio of new clinical devices. Both will play key roles leading our clinical and regulatory portfolios as the Company establishes clinical studies in the US and progresses its regulatory submissions to satisfy the FDA before clinical deployment.
Optiscan Imaging chief executive officer and managing director Dr Camile Farah
Dr Farah also said the complexity of the FDA regulatory pathway, combined with its device and drug combination product, requires the company to have local experts to support both the clinical and regulatory efforts required to secure the relevant approvals for its precision surgery and digital pathology technology.
Optiscan recently announced the receipt of a $3 million rebate from a Co-operative Research Centres Projects (CRC-P) grant, that will allow it to continue work on its Edge-AI-enabled gastrointestinal (GI) endomicroscope.
The $9.2 million project is a collaboration with Australian industry and science partners, CSIRO, Hydrix and Design & Industry.
The company also recently trousered $672,320 from a research and development grant administered by the ATO for the 2022-23 financial year. The incentive is an Australian Government program that allows companies to apply for cash rebates for up to 43.5 per cent of their eligible expenditure on R&D.
Optiscan appears to be in a solid financial position, holding cash and term deposits totalling more than $13.6 million as at the end of December 2023.
Management says the goal is to develop a second-generation GI, non-destructive medical endomicroscope – a miniature digital microscopy probe that will fit inside the biopsy channels of most endoscopes to provide real-time, slide-free images with a resolution capable of distinguishing sub-cellular structures.
It will utilise an AI engine set up to automatically detect and analyse cancerous and precancerous cells to accelerate the discovery and diagnosis of cellular pathologies and establish a greatly advanced standard of care.
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